acid reducer

Generic: omeprazole

Labeler: bi-mart
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acid reducer
Generic Name omeprazole
Labeler bi-mart
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
Bi-Mart

Identifiers & Regulatory

Product NDC 37835-189
Product ID 37835-189_cd7c9c63-7126-43f0-bca2-f0d263415e36
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206877
Listing Expiration 2026-12-31
Marketing Start 2018-06-06

Pharmacologic Class

Classes
cytochrome p450 2c19 inhibitors [moa] proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37835189
Hyphenated Format 37835-189

Supplemental Identifiers

RxCUI
402014
UPC
0071357912810
UNII
426QFE7XLK

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acid reducer (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA206877 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (37835-189-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (37835-189-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

37835-189-14 1 BOTTLE in 1 CARTON (37835-189-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 37835-189-42 3 BOTTLE in 1 CARTON (37835-189-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

omeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Acid Reducer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cd7c9c63-7126-43f0-bca2-f0d263415e36", "openfda": {"upc": ["0071357912810"], "unii": ["426QFE7XLK"], "rxcui": ["402014"], "spl_set_id": ["419659f9-098a-4a18-8bba-cd45157bfa50"], "manufacturer_name": ["Bi-Mart"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (37835-189-14)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "37835-189-14", "marketing_start_date": "20180606"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (37835-189-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "37835-189-42", "marketing_start_date": "20180606"}], "brand_name": "Acid Reducer", "product_id": "37835-189_cd7c9c63-7126-43f0-bca2-f0d263415e36", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "37835-189", "generic_name": "Omeprazole", "labeler_name": "Bi-Mart", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acid Reducer", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA206877", "marketing_category": "ANDA", "marketing_start_date": "20180606", "listing_expiration_date": "20261231"}